The Weight of Cardiovascular Disease

NCT ID: NCT06053645

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-22

Study Completion Date

2026-07-31

Brief Summary

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The purpose of this study is to evaluate the impact of a cardiometabolic clinic on percent body weight loss, body mass index (BMI), and visceral adiposity distribution in obese adults with cardiovascular disease (CVD) at 12 months.

Detailed Description

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Conditions

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Cardiovascular Diseases Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* BMI ≥30 kg/m2
* At least one of the following CVD: atrial fibrillation (AF), coronary artery disease (CAD), HFpEF (heart failure with preserved ejection fraction), HFrEF (heart failure with reduced ejection fraction), ACHD (adult congenital heart disease), or valvular heart disease
* Patients evaluated in the Cardiometabolic clinic
* Willingness to complete questionnaires/surveys
* Ability to complete monthly self-assessments at home

Exclusion Criteria

* BMI \<30 kg/m2
* Pregnancy or lactating women
* Hemodynamically unstable CVD
* Active malignancy
* Autoimmune or systemic inflammatory diseases
* Severe renal or hepatic failure
* Being considered unsafe to participate as determined by the study physician
* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic medications, or other medications as determined by the study NP or physician
* Patients with active psychosis, mania, or substance use disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kyla M. Lara-Breitinger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyla Lara-Breitinger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Preventive/Vascular Research Team

Role: CONTACT

(507) 538-7425

Kyla Lara-Breitinger, M.D.

Role: CONTACT

(507) 284-4441

Facility Contacts

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Preventive/Vascular Research Team

Role: primary

(507) 538-7425

Kyla Lara-Breitinger, M.D.

Role: backup

(507) 284-4441

Other Identifiers

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23-003696

Identifier Type: -

Identifier Source: org_study_id

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